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Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

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ClinicalTrials.gov Identifier: NCT01841450
Recruitment Status : Active, not recruiting
First Posted : April 26, 2013
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Tracking Information
First Submitted Date  ICMJE April 24, 2013
First Posted Date  ICMJE April 26, 2013
Last Update Posted Date July 31, 2018
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
Rate of sight-threatening adverse events [ Time Frame: 36 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 25, 2013)
Rate of sight-threatening adverse events [ Time Frame: 60 months ]
Change History Complete list of historical versions of study NCT01841450 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2018)
Other adverse events [ Time Frame: 36 months ]
For other adverse events such as increase in intra-ocular pressure (IOP) of ≥ 10 mmHg at any time postoperative, loss of best spectacle corrected visual acuity of ≥ 2 lines (≥ 10 letters) postoperative as compared to baseline or best recorded visual acuity measured at any visit postoperative, the rate of each event at each visit will be calculated for the two treatment groups separately.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2013)
Other adverse events [ Time Frame: 60 months ]
For other adverse events such as increase in intra-ocular pressure (IOP) of ≥ 10 mmHg at any time postoperative, loss of best spectacle corrected visual acuity of ≥ 2 lines (≥ 10 letters) postoperative as compared to baseline or best recorded visual acuity measured at any visit postoperative, the rate of each event at each visit will be calculated for the two treatment groups separately.
Current Other Pre-specified Outcome Measures
 (submitted: April 25, 2013)
Diurnal IOP reduction ≥ 20% [ Time Frame: Baseline and 24 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery
Official Title  ICMJE A Prospective, Controlled, Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery
Brief Summary The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate open-angle glaucoma.
Detailed Description The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery compared to cataract surgery only, in subjects with mild to moderate open-angle glaucoma.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Open Angle Glaucoma
Intervention  ICMJE
  • Device: iStent
    Implantation of one iStent in conjunction with cataract surgery
    Other Name: GTS100
  • Procedure: Cataract surgery
    Cataract surgery alone
Study Arms  ICMJE
  • Experimental: iStent
    Implantation of one iStent in conjunction with cataract surgery
    Intervention: Device: iStent
  • Active Comparator: Cataract surgery
    Cataract surgery alone
    Intervention: Procedure: Cataract surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2013)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • mild to moderate primary open-angle glaucoma
  • currently treated with ocular hypotensive medication
  • pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses
  • subject scheduled to undergo cataract surgery

Exclusion Criteria:

  • primary angle-closure glaucoma; or secondary angle closure glaucoma, including neovascular glaucoma
  • retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of condition that may cause elevated episcleral venous pressure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01841450
Other Study ID Numbers  ICMJE GTS100-PAS2 (Rev1 04-11-2016)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Glaukos Corporation
Study Sponsor  ICMJE Glaukos Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Glaukos Corporation
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP